FDA Device Establishments · JSON-LD · Markdown
FEI 3010663777 · Manufacture Medical Device · Status: Active
| FEI Number | 3010663777 |
|---|---|
| Owner / Operator | FUKUDA DENSHI CO., LTD. (#9028352) |
| Address | 5 Technohills, Taiwa-cho, Kurokawa-gun Miyagi, 981-3629, JP |
| Mandatory US Agent | Fukuda Denshi USA, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | IYN, ITX, IYO |
| Regulation § (21 CFR) | 892.1550, 892.1570, 892.1560 |
| Proprietary names | Sigma 5000 Series Ultrasound |
Source: openFDA. Public-domain (CC0).